Giuseppe Patti1, Markus Lucerna2, Ilaria Cavallari3, Elisabetta Ricottini3, Giulia Renda4, Ladislav Pecen5, Fabio Romeo6, Jean-Yves Le Heuzey7, Josè Luis Zamorano8, Paulus Kirchhof9, Raffaele De Caterina10. 1. Department of Cardiovascular Sciences, Campus Bio-Medico University of Rome, Rome, Italy. Electronic address: g.patti@unicampus.it. 2. Daiichi-Sankyo Europe, Munich, Germany. 3. Department of Cardiovascular Sciences, Campus Bio-Medico University of Rome, Rome, Italy. 4. G. d'Annunzio University of Chieti, Chieti, Italy. 5. Institute of Informatics, Academy of Sciences of Czech Republic, Prague, Czech Republic. 6. Daiichi-Sankyo Italy, Rome, Italy. 7. Cardiology and Arrhythmology, Georges Pompidou Hospital, René Descartes University, Paris, France. 8. Department of Cardiology, University Hospital Ramòn y Cajal, Madrid, Spain. 9. Institute of Cardiovascular Sciences, University of Birmingham and Sandwell and West Birmingham Hospitals and University Hospitals Birmingham NHS Trust, Birmingham, United Kingdom; Hospital of the University of Münster, Münster, Germany. 10. G. d'Annunzio University of Chieti, Chieti, Italy; Fondazione G. Monasterio, Pisa, Italy. Electronic address: rdecater@unich.it.
Abstract
BACKGROUND: Diabetes is a known risk predictor for thromboembolic events in patients with atrial fibrillation (AF), but no study has explored the prognostic weight of insulin in this setting. OBJECTIVES: This study evaluated the differential role of insulin versus no insulin therapy on thromboembolic risk in patients with diabetes and AF. METHODS: We accessed individual patient data from the prospective, real-world, multicenter, PREFER in AF (European Prevention of thromboembolic events-European Registry in Atrial Fibrillation). We compared the rates of stroke/systemic embolism at 1 year according to diabetes status (no diabetes, diabetes without insulin therapy, diabetes on insulin therapy). RESULTS: In an overall population of 5,717 patients, 1,288 had diabetes, 22.4% of whom were on insulin. For patients with diabetes who were on insulin, there was a significantly increased risk of stroke/systemic embolism at 1 year versus either no diabetes (5.2% vs. 1.9%; hazard ratio: 2.89; 95% confidence interval: 1.67 to 5.02; p = 0.0002) or diabetes without insulin treatment (5.2% vs. 1.8%; hazard ratio: 2.96; 95% confidence interval: 1.49 to 5.87; p = 0.0019). Notably, rates of stroke/embolism were similar in patients with diabetes not receiving insulin versus patients without diabetes (hazard ratio: 0.97; 95% confidence interval: 0.58 to 1.61; p = 0.90). The selective predictive role of insulin-requiring diabetes was independent of potential confounders, including diabetes duration, and was maintained in various subpopulations, including the subgroup receiving anticoagulant therapy. CONCLUSIONS: In this cohort of anticoagulated patients with AF, the sole presence of diabetes not requiring insulin did not imply an increased thromboembolic risk. Conversely, insulin-requiring diabetes contributed most, if not exclusively, to the overall increase of thromboembolic risk in AF.
BACKGROUND: Diabetes is a known risk predictor for thromboembolic events in patients with atrial fibrillation (AF), but no study has explored the prognostic weight of insulin in this setting. OBJECTIVES: This study evaluated the differential role of insulin versus no insulin therapy on thromboembolic risk in patients with diabetes and AF. METHODS: We accessed individual patient data from the prospective, real-world, multicenter, PREFER in AF (European Prevention of thromboembolic events-European Registry in Atrial Fibrillation). We compared the rates of stroke/systemic embolism at 1 year according to diabetes status (no diabetes, diabetes without insulin therapy, diabetes on insulin therapy). RESULTS: In an overall population of 5,717 patients, 1,288 had diabetes, 22.4% of whom were on insulin. For patients with diabetes who were on insulin, there was a significantly increased risk of stroke/systemic embolism at 1 year versus either no diabetes (5.2% vs. 1.9%; hazard ratio: 2.89; 95% confidence interval: 1.67 to 5.02; p = 0.0002) or diabetes without insulin treatment (5.2% vs. 1.8%; hazard ratio: 2.96; 95% confidence interval: 1.49 to 5.87; p = 0.0019). Notably, rates of stroke/embolism were similar in patients with diabetes not receiving insulin versus patients without diabetes (hazard ratio: 0.97; 95% confidence interval: 0.58 to 1.61; p = 0.90). The selective predictive role of insulin-requiring diabetes was independent of potential confounders, including diabetes duration, and was maintained in various subpopulations, including the subgroup receiving anticoagulant therapy. CONCLUSIONS: In this cohort of anticoagulated patients with AF, the sole presence of diabetes not requiring insulin did not imply an increased thromboembolic risk. Conversely, insulin-requiring diabetes contributed most, if not exclusively, to the overall increase of thromboembolic risk in AF.
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